NARAMIN- diphenhydramine hydrochloride solution

NARAMIN by

Drug Labeling and Warnings

NARAMIN by is a Otc medication manufactured, distributed, or labeled by National Pharma Industries Inc, Plastikon Healthcare, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

NARAMIN Antihistamine Oral Solution

Active ingredient (per 5 ml = one pre-filled whistle)*

Diphenhydramine HCl 12.5 mg

Purpose

Antihistamine

Uses

For the temporary relief of these symptoms due to hay fever or other upper respiratory allergies:

• runny nose
• sneezing
• itching of the nose or throat
• itchy, watery eyes

Warnings

Do not use

• to make a child sleepy
• with any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if you have

• glaucoma
• difficulty in urination due to enlargement of the prostate gland
• a sodium-restricted diet
• a breathing problem such as emphysema or chronic bronchitis

Ask a doctor or pharmacist before use if you

are taking sedatives or tranquilizers

When using this product

marked drowsiness may occur

avoid alcoholic beverages

alcohol, sedatives, and tranquilizers may increase the drowsiness effect

use caution when driving a motor vehicle or operating machinery

excitability may occur, especially in children

Choking Hazard: Small parts. Keep out of reach of children.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

• Adults and children 12 years of age and over:

  Take 2-4 pre-filled whistles every 4 to 6 hours, not to exceed 24 whistles in 24 hours, or as directed by a doctor

• Children 6 to under 12 years of age:

  Take 1-2 pre-filled whistles every 4 to 6 hours, not to exceed 12 whistles in 24 hours, or as directed by a doctor

• Children under 6 years of age:

  Consult a doctor

Other information

• Each pre-fille whistle contains 14 mg of sodium
• Protect from light.
• SAFETY SEALED: This product is protected by a sealed pouch. Do not use if individual foil pouch is torn or damaged.
• Whistle is not child resistant. Do not remove whistle from child resistant foil pouch prior to use.
• Store between 68 degrees-77 degrees F (20 degrees - 25 degrees C)
• Store in outer carton until contents are used.

Inactive ingredients

anhydrous citric acid, DandC red no. 33, FDandC red no.40, flavor, glycerin, monoammonium glycyrrhizinate, poloxamer 407, sodium benzoate, sodium chloride, sodium citrate, sucrose, water

Questions or comments?

1-855-251-0106

NARAMIN Antihistamine Oral Solution 10-5ml whistles (

58292-010-05)

INGREDIENTS AND APPEARANCE

NARAMIN 
diphenhydramine hydrochloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58292-010
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	12.5 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)
POLOXAMER 407 (UNII: TUF2IVW3M2)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SUCROSE (UNII: C151H8M554)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	RED	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58292-010-05	10 in 1 PACKAGE
1		5 mL in 1 AMPULE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	05/28/2014

Labeler - National Pharma Industries Inc (078725867)

Establishment
Name	Address	ID/FEI	Business Operations
Plastikon Healthcare, LLC		041717941	manufacture(58292-010)